The Schafer Autism Report
  Tuesday, December 19, 2005            [EXPERIMENTAL DESIGN]                                           Vol. 9  No. 201


   * House OKs Drug Maker Liability Safeguards

   * The Age of Autism: The Story So Far

   * Polluted Town Alarmed by Shortage of Sons


    * Oxygen Deprivation May Contribute to Autism


  * Immunizing The Drug-Makers

House OKs Drug Maker Liability Safeguards

      By Kevin Freking for the Associated Press.  

      Drug manufacturers are a step closer toward winning the liability protections they say they need before investing in medicines to combat a bird flu pandemic.

From the A-CHAMP Action Center

Take 11th Hour Action to Prevent Drug Makers Martial Law Sneak Protection!  Go Here

     Opponents described the protections, approvedearly Monday by the House, as a "massive Christmas bonus to the drug companies."
     Consumers seeking damages on

claims they were  harmed by a vaccine would have to prove willful misconduct on the part of the drug manufacturers. That is a higher standard than negligence, used in many product liability cases.
      "Negligence is much easier to prove; it's the failure to exercise reasonable care," said Carl Tobias, a professor at the University of Richmond School of Law. "Willful misconduct is a much higher standard. You must intentionally misbehave. ... The high standard would clearly discourage many suits."       Senate Majority Leader Bill Frist, R-Tenn. led the fight for the additional protections. Amy Call, a Frist spokeswoman, said drug companies don't view flu vaccine as profitable and won't get in the business if the potential liabilities outweigh the potential benefits.
      "When you're asking a company to come in and develop something new that they won't make money off, ... there's no reason for them to get into the market," Call said.
      Frist attached the legislation to the Defense Appropriations Bill, a bill viewed by lawmakers as must-pass because it will fund military operations in Afghanistan and Iraq. The Senate will take up the bill Wednesday or Thursday.
      Democrats opposed attaching the liability protections to the defense bill, as well as the substance of the legislation.

      "This liability shield can be granted to any product used to prevent or treat an epidemic or a pandemic, and the secretary gets to decide what that means. No court can review that decision," said Rep. Henry Waxman, D-Calif. "But for those who may be injured, Washington Republicans had only a lump of coal: a compensation program without a single penny of funding."
      Trial lawyers also attacked the legislation.
      "In the dead of night when no one was watching, U.S. Senator Bill Frist provided his corporate friends in the drug industry with an unprecedented giveaway that puts the health and safety of Americans at risk," said Ken Suggs, president of the Association of Trial Lawyers of America.
      "The trial lawyers apparently would prefer to keep filing frivolous lawsuits and collecting excessive attorney fees rather than making sure public health is protected and injured parties are compensated," Call replied.
      Call said the legislation puts in place a compensation system modeled after what Congress approved for those who experience harmful side effects from the smallpox vaccine. Under the program, pandemic flu vaccine recipients or their families could apply for lost income, medical expenses and death

      But Democrats said the legislation appropriates no money for the compensation fund, and they question whether Republicans ever will fund it.
      The defense bill also sets aside $3.8 billion for improved pandemic preparedness - but that's just slightly more than half of what the president requested a few weeks ago.
      Fears of a pandemic have increased in recent months as a virus infecting millions of birds has spread throughout Asia and parts of Europe. While the virus has not yet appeared in the United States, or spread from person to person, officials worry the bird flu could eventually mutate and create a global health crisis because people have no immunity to the virus.
      Most of the funding, about $3.3 billion, would go to the Department of Health and Human Services, mostly for the purchase of vaccines and antivirals, for state and local planning, and for improved surveillance.
      A spokesman for the department said the appropriation was in line with what the administration had planned on spending this year - even though it's much less than what the president requested.
      "It's a good start and we'll be back next year to continue the work," said HHS spokeswoman Christina Pearson.

The Age of Autism: The Story So Far
Part 1 of 3

By Dan Olmsted for UPI

      In February, we began this ongoing series of articles on the roots and rise of autism. Now, at the end of the year, here's a summary of our story so far:
      -- Something happened among children born in the early 1930s to bring autism to the attention of Leo Kanner, the eminent and experienced Johns Hopkins University psychiatrist who first described the disorder in a landmark 1943 paper. At the same time, a Viennese pediatrician named Hans Asperger was noticing a remarkably similar, though somewhat less severe, syndrome that came to bear his name.
      In our first column, "Donald T. and Fritz V.," we found it amazing that these first two patients -- Donald in the United States and Fritz in Austria -- were born within four months of each other in 1933. Yet these 

unique, impossible-to-miss children with Autism Spectrum Disorders had been around in similar numbers since the dawn of time?
      Experts disagree, but our first and still-tentative conclusion is that's just plain unlikely. Scattered cases, sure. But 1 in 166, the current U.S. autism rate in children? We don't see it.
      -- Instead, it appears more likely something happened around 1930 to set off the age of autism. Clearly, there are clues in the striking commonalities among the first U.S. families stricken with the disorder. They were college-educated; many had advanced degrees; four of the fathers in the first 11 families identified by Kanner were medical doctors -- psychiatrists, to be precise. There were professors, lawyers, scientists, engineers. One mother was also a doctor, and all of them were smart, accomplished women.
      Some think that suggests a "geek effect," in which gummed-up genes finally find each other and generate offspring who aren't just brainy and distracted, they're downright autistic. Based on our own reporting, we don't buy that -- where were all the autistic offspring of geeks before 1931, the year the oldest child ever diagnosed by Kanner was born?
      Coincidence or not, 1931 appears to be the first year in which U.S. vaccines


contained a mercury preservative called thimerosal, and that yields an alternate hypothesis that could explain the decisive increase in cases that we think is probable. Some parents and a minority of scientists now believe thimerosal -- which is about half ethyl mercury by weight -- is behind most autism cases, perhaps triggering the disorder in a genetic subset of children who lack the ability to excrete it.
      Although it wasn't fully understood at the time, organic mercury is a potent neurotoxin in even minute quantities; beginning in 1999 thimerosal was phased out of routine childhood immunizations, though federal health authorities say it is safe in that form, and they stand by its continued use in flu shots for pregnant women and toddlers.
      An alternative to the "geek theory" is that those first 11 families back in the 1930s -- especially the ones with links to the medical world -- would have had had the information, income and access to take advantage of the latest health innovations and vaccinate themselves and their children.
      A related hypothesis was proposed to us by Mark Blaxill, a director of the anti-mercury-in-medicine group SafeMinds. He suggested an association between several more of those first 11 cases and ethyl-mercury-based fungicides that came on

the market at the same time, patented by the same scientist who developed thimerosal.
      Case 1 in Kanner's study -- Donald T., born in 1933 -- came from an area surrounded by a forest being replanted with seedlings by the Civilian Conservation Corps.
      Case 2's father was a plant pathologist. Case 3's was a forestry professor at a Southern university. Case 4's was a mining engineer. Case 8's was a chemist-lawyer at the U.S. Patent Office. All of them might have come in contact with mercury or other toxic compounds.
      Given this intriguing though by no means conclusive set of associations, it's possible those parents were not in fact passing on malignant mutations of the genes that made them doctors, forestry professors, plant pathologists, chemists. Rather, through their particular professions they might have exposed their children to something wholly new in commercial medical and agricultural products, something they did not know was devastatingly neurotoxic to developing brains.
      That might make the age of autism, in effect, the age of organic mercury.
      Not that it proves anything, but looking back recently through the groundbreaking book "Infantile Autism" by Bernard Rimland, something struck us that we hadn't noticed before. This 1964 work is widely credited with

single-handedly debunking the idea that "refrigerator mothers" or aloof fathers caused autism.
      Reviewing the rare descriptions of children with autistic-type behavior prior to Kanner's 1943 paper, Rimland noted a case that "sounds very much like autism." That child's father, Rimland said, "was a Ph.D."
      A professor of chemistry.
      That's the kind of detail that means nothing to the experts looking for incredibly complex gene interactions to explain autism, but it makes our layman's hair stand on end.
      As we pressed to find more about those early cases, the trail led all the way back to Case 1 himself, and to a small town in Mississippi.
      We'll go there next.
NOTE: PART 2 of this series, "The Age of Autism: Missing in Mississippi" is at this UPI link:

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Polluted Town Alarmed by Shortage of Sons

      By Matt Crenson, AP

      Aamjiwnaang First Nation, Canada - Growing up with smokestacks on the horizon, Ada Lockridge never thought much about the pollution that came out of them.
      She never worried about the oil slicks in Talfourd Creek, the acrid odors that wafted in on the shifting winds or even the air-raid siren behind her house whose shrill wail meant "go inside and shut the windows."
      Now Lockridge worries all the time.
      A budding environmental activist, she recently made a simple but shocking discovery: There are two girls born in her small community for every boy. A sex ratio so out of whack, say scientific experts who helped her reveal the imbalance, almost certainly indicates serious environmental contamination by one or more harmful chemicals.
      The question: Which ones? And another, even more pressing question: What else are these pollutants doing to the 850 members of this Chippewa community? Lockridge and her

neighbors live just across the U.S.-Canada border from Port Huron, Mich., on the Aamjiwnaang First Nation Reserve. For nearly half a century, their land has been almost completely surrounded by Canada's largest concentration of petrochemical manufacturing.
      Much of their original reserve, founded in 1827, was sold out from under them via questionable land deals in the 1960s. It is now occupied by pipelines, factories and row upon row of petroleum storage tanks.
      The area is so dominated by the industry that it is referred to on maps and in local parlance as "Chemical Valley."
      About two years ago, Suncor Energy - which already operates a refinery and petrochemical plant next to the Aamjiwnaang reserve - proposed adding another factory to the mix, an ethanol plant to be built on one of the few undeveloped parcels adjoining the community's property.
      Lockridge and other members of the band joined to oppose the plant. They asked biologist Michael Gilbertson to look at a binder full of technical information about air, water and soil contamination on the reserve.
      In a conference call, he reported that the data showed elevated levels of dioxin, PCBs, pesticides and heavy metals including arsenic, cadmium, lead and mercury.

      Almost as an afterthought, he asked a question: Had anybody noticed a difference in the number of girls and boys in the community? At the other end of the line, the Aamjiwnaang and their allies were suddenly abuzz.
      "All of a sudden everybody in that room started talking," said Margaret Keith, a staffer for the Occupational Health Clinic for Ontario Workers, a public health agency.
      Somebody pointed out that the reserve had fielded three girls' baseball teams in a recent year and only one boys' team. Lockridge thought about herself and her two sisters, with eight daughters among them and only one son.
      The question was not as offhand as it seemed. "I had been interested in sex ratio as an indicator - a very sensitive indicator of effects going on as a result of exposure to chemicals," Gilbertson said in a recent interview.
      Gilbertson explained that certain pollutants, including many found on the Aamjiwnaang reserve, could interfere with the sex ratio of newborns in a population. Heavy metals have been shown to affect sex ratio by causing the miscarriage of male fetuses. Other pollutants known as endocrine disrupters - including dioxin and PCBs - can wreak all sorts of havoc by interfering with 

the hormones that determine whether a couple will have a boy or a girl.
      If some pollutant was skewing the distribution of girls and boys in her family and her community, Ada Lockridge thought, what else could it be doing? Statistics indicate that one in four Aamjiwnaang children has behavioral or learning disabilities, and that they suffer from asthma at nearly three times the national rate. Four of 10 women on the reserve have had at least one miscarriage or stillbirth.
      "I was throwing up thinking about what was in me," said Lockridge, who is 42. "I cried. And then I got angry."
      She got a copy of the band membership list, and tallied the number of boys and girls born in each year since 1984. Sure enough, the percentage of boys started dropping below 50 percent around 1993. It is now approaching 30 percent, with no sign of leveling off.
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Oxygen Deprivation May Contribute to Autism

      By Randy Dotinga

      HealthDay News - New research with rats suggests that oxygen deprivation during birth could be a contributing cause of autism.
      There's no easy way to test the oxygen-deprivation theory in humans, and the finding isn't likely to lead to better treatments in the near future. Still, the research gives scientists greater insight into how factors other than genetics may play a role in autism, said Fabrizio Strata, a neuroscience researcher at the University of California, San Francisco and co-author of the study.
      Symptoms of autism, the most common condition in a group of developmental disorders known as autism spectrum disorders, can range from mild to severe. The disability usually strikes by age 3. It lasts a lifetime, and there is no cure, although some people with autism can learn to function well.
      According to the U.S. Centers for Disease Control and Prevention, autism is

characterized by three distinctive behaviors. Autistic children have difficulties with social interaction, display problems with verbal and nonverbal communication, and exhibit repetitive behaviors or narrow, obsessive interests. Scientists are not certain what causes autism, but it is likely that both genetics and environment play a role.
      For reasons that aren't clear, autism seems to have become more common in recent years. One hotly debated theory suggests that vaccines are responsible, although some studies have failed to find a link.
      Oxygen deprivation during birth is considered one possible cause because it can lead to brain damage.
      By boosting the level of nitrogen in the air, Strata and colleagues deprived rat pups of normal levels of oxygen for as long as 10 to 12 minutes during birth. When the rats grew older, they displayed symptoms similar to those found in autistic children. It took longer for the rats to respond to some sounds, for example, and the brain regions that handle sound were disrupted.
      Why would a baby be oxygen-deprived in the first place? According to Strata, a complicated labor can cut off a newborn's oxygen supply, as can a twisted umbilical cord.

      Andy Shih, chief science officer with the National Alliance for Autism Research, said the oxygen-deprivation study presents an "interesting hypothesis," although the research hasn't been confirmed in humans.
      It's possible that future research could lead to changes in obstetric practices to minimize the chance that babies will go without oxygen, Shih said. But "we're far away from that at this point."
      The study findings appear in the Dec. 19-24 issue of the Proceedings of the National Academy of Sciences.
Brief commentary: this is a stillborn hypothesis absent reports of epidemics of twisted umbilical cords and complicated labors to account for the subsequent present epidemic of autism. - LS




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Immunizing The Drug-Makers
      From the Milwaukee Journal Sentinel . 

      The House ostensibly took steps early Monday to protect Americans from a bird flu epidemic, but the people who were really being protected are the vaccine-makers. And unless the Senate rejects the House action, which it is expected to consider later this week, Congress will have given big business an immunization - against civil lawsuits by patients injured by flu vaccines.
      That's both wrong and unnecessary.
      As one of the riders on the defense appropriations bill, the House Monday granted sweeping legal immunity to companies that produce vaccines in response to a potentially deadly flu pandemic. Those pushing for such immunity, including President Bush and Senate Majority Leader Bill Frist (R-Tenn.), say the protection is needed to convince vaccine-makers to start making influenza vaccine, especially with the looming threat of bird flu.
      While that may seem reasonable - and even responsible from a public health standpoint - it doesn't reflect economic 

      Yes, as Bush and Frist say, there has been a disturbing and steady retreat by American companies from the vaccine business over the past 20 years. But the reason, consumer advocates legitimately argue, isn't so much the concern about liability.
      This was borne out by a study by two professors in the Harvard University School of Public Health, published in a recent issue of the Journal of the American Medical Association. The professors concluded that low profits and unpredictable demand, not litigation, were the primary reasons drug companies had been pulling out of the vaccine business. Last year, Anthony Fauci, the highly respected chief of infectious disease for the National Institutes of Health, essentially told The Associated Press the same thing.
      What's more, some companies, including Sanofi Pasteur, the largest supplier of flu vaccine to the United States, have already started working on avian flu vaccines, even though there is no sweeping immunity currently in place in the U.S.
      While it's reasonable to have some liability protections in place for drug companies against frivolous lawsuits, consumer advocates, including the Center 

for Justice and Democracy, argue convincingly that this legal shield, which would get triggered by a declaration of emergency from the secretary of health and human services, amounts to blanket immunity. Injured parties would have to prove that the companies engaged in "willful" misconduct or neglect - an exceedingly difficult task.
      The measure would have even more ominous implications for consumers because the protections could be extended not just to vaccines but to other products, even over-the-counter medications, in an epidemic.
      In short, this is bad medicine. And when it gets its chance, the Senate should spit it out.

From the A-CHAMP Action Center

Take Action!
Frist Gives Parents the Slip Again;
Leadership in Congress Muscles Drug Company Liability Provision into Unrelated Defense Bill
Bill Gives Immunity to Pharma;
Also Preempts State Laws Banning Thimer

In the middle of the night, Senator Frist used raw political muscle to impose sweeping, never-before-seen immunity for drug companies into the Department of Defense Appropriations Conference Report.  The language constitutes an unprecedented wish-list of liability protections that will allow the industry to recklessly injure or kill Americans with contaminated drugs and vaccines and never be held accountable.  This language offers more special interest immunity than any bill ever considered by either body of the Congress. You can read the provision by going here and downloading a pdf.

The language also would allow preemption of state laws providing for safe vaccines, such as laws banning mercury in vaccines. If the President or his admininistration say so this law would allow the production of vaccines containing mercury even if your state has a law banning it. The people who backed this legislation have no respect for states like California, Iowa, Illinois, Delaware, Missouri and New York, whose citizens have sent a clear message: KEEP MERCURY OUT OF VACCINES.

Below is a list of the key provisions in this bill. If any of them bother you TAKE ACTION, send a letter, or fax or use A-CHAMP's email messaging system. Use our sample letter or write your own. 

You can find your Senator's contact information here:
We especially need our Republican parents and friends to write their Senators. Without the critical support of key Republican Senators the Eli Lilly Rider, immunity legislation that was enacted in 2002, would never have been repealed. (Thank you Senators Collins, Snowe and Chafee, among others).

Key Provisions of the immunity provisions in HR 2863 that will be considered by the Senate this week (Senate number is not assigned yet). 

Take Action!

Six objectionable things that the new immunity legislation will do: 

1) Allows use of Thimerosal in vaccines:
If the Secretary of Health and Human Services designates that a vaccine is a "covered countermeasure" thimerosal can be used in the vaccine,  even if your state has banned Thimerosal. Any state legislation covering vaccines would be rendered ineffective and Federal law would preempt all state provisions.

2) Immunity for ALL Drugs and Vaccines:
The language could potentially apply to any drug, vaccine, or biological product that the Secretary of HHS deems a “covered countermeasure.”  This list could include any commercial drug like Tylenol and is not limited in any way to drugs or vaccines meant to treat a pandemic like avian flu. 

3) Immunity at ANY Time:
The immunity language depends on the Secretary making a declaration that a health condition is causing a public health emergency or that some

health condition could become an emergency at some point in the future.  There is nothing that limits this declaration to an actual health emergency or to an actual pandemic illness.  This declaration could occur at any time for almost any reason.

4) Immunity for Harm Caused by a Manufacturer’s Bad Conduct:
The immunity applies no matter what the drug company did wrong.  Even if a drug company operates a dirty facility in which a batch of vaccines is contaminated, and that vaccine kills thousands of Americans, the drug company is immune from liability. 

5) Immunity for Anything but Assault or Murder:
The language explicitly protects drug companies who act recklessly or who are grossly negligent, and would allow a claim to go forward only where a drug company acted with such willful misconduct as to constitute criminal assault or murder.  Anything less than criminal conduct is protected.

6) Immunity for Murder unless the Secretary or the Attorney General Say Otherwise:
Even if a drug company has acted with “willful misconduct” as defined by this language, the drug company is still immune from accountability unless the Secretary or the Attorney General initiates an enforcement action against the drug company and that action is pending at the time a claim is filed or 

the action resulted in some form of punishment. So even if a drug company knowingly kills thousands of people, if no official enforcement action is taken, that company is still immune.  

Take Action to Stop this Outrageous Legislation! 

Or go here  to find your Senators telephone  or fax number - call and fax!

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